Tricia Thompson, MS, RD

Menu

FDA Gluten-Free Labeling Rule Finalized!

My apologies for the long post. Each section stands alone and there is no reason to read this article in one sitting!! What is provided below is my personal compilation of information from the gluten-free labeling rule, the executive summary of the rule, the Q&A section written by FDA, and previous blog posts I have written on various issues. Please see the end of the article for links to sources.

Section One: Summary of the Rule

1. This rule applies to the labeling of foods as packaged (including dietary supplements) regulated by the Food and Drug Administration and intended for human use.

Note: This rule does not apply to pet foods, cosmetics, prescription and non prescription drugs, food regulated by the United States Department of Agriculture, and beverages regulated by the Alcohol Tobacco Tax and Trade Bureau.

2. A food labeled gluten-free:

Is inherently gluten-free (e.g., raw carrots)

OR

Adheres to the following criteria:

Does not contain an ingredient that is a gluten-containing grain (e.g., wheat)

Does not contain an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour)

May contain an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch) as long as use of that ingredient in the food does NOT cause the food to contain 20 ppm or more gluten

AND

Any unavoidable presence of gluten in the food is less than 20 ppm gluten.

Note: The FDA states in the Executive Summary of the rule that, “Manufacturers making a gluten-free claim must ensure that foods do not contain 20 ppm or more gluten, including the unavoidable presence of gluten due to cross-contact or migration from packaging materials.”

3. Terms synonymous with “gluten-free” when used on a food label are:

“No gluten”

“Free of gluten”

“Without gluten”

Food labels making the above claims must comply with the gluten-free labeling rule.

Note: The statements, “made with no gluten-containing ingredients” and “not made with gluten-containing ingredients” are allowed statements on food labels and these products do NOT have to comply with gluten-free labeling rules UNLESS a gluten-free claim also is made.

4. If a food is labeled gluten-free and also includes the word “wheat” in the ingredients list or Contains statement due to the use of ingredients such as “wheat starch” (which may contain residual wheat protein) the word “wheat” must be followed by an asterisk and the statement, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”

Note: This stipulation applies to ingredients in an FDA-regulated food as outlined in the Food Allergen Labeling and Consumer Protection Act. This stipulation does NOT apply to voluntary allergen advisory statements (e.g., processed in a facility that also processes wheat) related to manufacturer processing practices. These statements may be included on foods labeled gluten-free without additional clarifying language. However, foods with allergen advisory statements for wheat that also are labeled gluten-free must comply with the gluten-free labeling rule.

Q: Do foods regulated by the USDA and beverages regulated by the TTB have to comply with the FDA’s gluten-free labeling rule?

A: No. The USDA regulates meat products, poultry products, egg products (dried, frozen, or liquid eggs, with or without added ingredients), and mixed food products that generally contain no more than 3% raw meat, or 2% or more cooked meat or poultry meat. The easiest way to tell whether a product is regulated by the USDA is to look for the egg products shield or the USDA mark of inspection.

A few years ago I was told the following about gluten-free labeling via email correspondence with the USDA, “FSIS is not planning at this time to conduct rulemaking to define ‘gluten free.’ Rather, once FDA’s final rule becomes effective, if a meat, poultry, or egg product establishment chooses to make the claim ‘gluten free’ they will need to follow the requirements for the use of the claim in FDA’s regulations. This is similar to what FSIS has required when establishments choose to make health claims and label trans-fat on meat, poultry, and egg products (i.e., FSIS allows the use of FDA regulated health claims and the declaration of trans-fat on labels provided the establishments follows FDA’s regulations). This would ensure consistency for the use of the claim ‘gluten free’ across all food groups for consumers. FSIS will clarify this position through policy guidance published on its web-site.” Once I have more information, I will post it.

The FDA’s gluten-free labeling rule also does not apply to alcoholic beverages regulated by the TTB. The TTB regulates almost all alcoholic beverages–all distilled spirits, wines that contain 7% or more alcohol by volume, and malted beverages (e.g., beer) that are made with BOTH malted barley and hops.

The TTB has issued an interim policy on gluten-free labeling of alcoholic beverages under its jurisdiction. Under the interim policy, the TTB:

Will not allow gluten-free claims to be included on product labels or in product advertising if the alcohol is made with wheat, barley, rye, or crossbred varieties of these grains OR any ingredients derived from these grains.

Will allow gluten-free claims on products labels and in advertisements if the alcohol is made without wheat, barley, rye, or crossbred varieties of these grains OR ingredients derived from these grains. BUT producers must ensure that their raw ingredients and finished products (among other things) are NOT cross-contaminated with gluten.

Will allow the statement, “Processed or treated or crafted to remove gluten” for products made with wheat, barley, rye, or crossbred varieties of these grains OR any ingredients derived from these grains IF these grains or ingredients have been processed (or treated or crafted) to remove all or some of the gluten IF

One of the following statements is also included on the product label or in the advertisement:

“Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten.” OR

“This product was distilled from grains containing gluten, which removed some or all of the gluten. The gluten content of this product cannot be verified, and this product may contain gluten.”

Q: Must manufacturers who label foods gluten-free test these foods for gluten?

A: NO.

Q: If the FDA tests food for gluten as part of rule enforcement what tests will they use?

A: At present the FDA states that they will use two sandwich enzyme-linked immunosorbent assays (ELISA)-based methods (R5 ELISA from R-Biopharm and Wheat Protein ELISA Kit (gliadin) from Morinaga).

Q: How is the FDA handling foods made from hydrolyzed or fermented ingredients?

A: First a little background information… What is known as a sandwich ELISA is used to assess the gluten content of foods when the gluten protein is intact or relatively intact. With this type of assay, two epitopes or antibody binding sites are needed. When an ingredient or food is hydrolyzed or fermented the gluten protein is broken into smaller protein fragments. These peptides may no longer contain two epitopes. As a result gluten content may be underestimated if the food is assessed using a sandwich ELISA.

For example consider the following protein where “QQPFP” represents the epitope and “a” represents other amino acids:

aaaaaQQPFPaaaaaaaaaaaaaaaQQPFPaaaQQPFPaaaaaaQQPFP

If this protein undergoes hydrolysis, the following three fragments may result:

1. aaaaaQQPFP

2. aaaaaaaaaaaaaaaQQPFPaaaQQPFP

3. aaaaaaQQPFP

The sandwich R5 ELISA (which utilizes the R5 monoclonal antibody to potentially celiac toxic epitope QQPFP) would be unable to measure the first or the third protein fragments because these peptides contain only one QQPFP epitope. Only the second protein fragment would be measured by the sandwich R5 ELISA.

When only one epitope or antibody binding site is available (which may be the case when ingredients/foods are fermented or hydrolyzed) a competitive ELISA (e.g., competitive R5 ELISA) should be used.

BUT the FDA does not consider these methods scientifically valid for the purposes of analyzing fermented or hydrolyzed foods to determine compliance with the gluten-free labeling rule. The agency states, “Evidence in the scientific literature is currently lacking about a scientifically valid competitive ELISA method which confirms that any gluten peptides detected in a food sample can be accurately quantified in terms of ppm intact gluten protein.”

The FDA is planning rule-making for fermented or hydrolyzed foods or foods that use fermented or hydrolyzed ingredients. In the meantime, the FDA is allowing gluten-free claims on these products provided they meet all of the requirements for bearing a gluten-free claim even though the gluten content cannot be reliably measured. This proposed rule will include discussion of distilled vinegar, malt, malt extract, and beer under the jurisdiction of the FDA (i.e., beer that is NOT made from BOTH barley and hops).

Note: This provision applies to fermented or hydrolyzed ingredients derived from gluten-containing ingredients that have been processed to remove gluten, such as wheat starch hydrolysates (e.g., wheat-based glucose syrup, wheat-based maltodextrin). It does not apply to ingredients derived from gluten-containing grains that have not been processed to remove gluten (e.g., hydrolyzed wheat protein).

Note: It appears that the competitive R5 may have finally been validated. The AACC International very recently published a technical report on the findings of a collaborative study on the competitive R5 ELISA. One of the study authors sent me a pre-print version of the paper. This international collaborative study to validate the competitive R5 ELISA (Ridascreen Gliadin Competitive R7021, R-Biopharm) was jointly run by the Prolamin Working Group and AACCI. This multi-lab performance trial involved 16 labs and 7 foods/beverages. By means of comparison, when the sandwich R5 ELISA (Ridascreen Gliadin R7001, R-Biopharm) was validated in a collaborative trial with the Prolamin Working Group, 20 labs and 12 food samples were involved. To the best of my knowledge neither the FDA nor the TTB has commented publicly on this collaborative trial

Q: Is food served in restaurants covered by the gluten-free labeling rule?

A: The FDA does not provide a simple yes or no answer to this question. In their Q&A section it is stated, “With respect to restaurants, FDA guidance suggests that any use of an FDA-defined food labeling claim (such as “fat free” or “low cholesterol”) on restaurant menus should be consistent with the respective regulatory definitions. This same approach would be followed with respect to “gluten-free” claims made in restaurants and other retail food service establishments.” In the Executive Summary the following statement is made, “With respect to restaurants, FDA guidance suggests that any use of an FDA-defined food labeling claim (e.g., “fat free” or “low cholesterol”) on restaurant menus should be consistent with the respective regulatory definitions (Ref. 35).

Ref 35 is a document entitled, “Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods.” It contains nonbinding recommendations. The document goes on to say, “While ‘A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods’ represents the best advice of FDA, it does not have the force and effect of law” and “The use of the word should in Agency guidances means that something is suggested or recommended, but not required.” The entire guidance can be read at http://tinyurl.com/knqutmz

Section Three: My thoughts…

There are several parts of the Gluten-Free Labeling Rule and Executive Summary that in my opinion are going to require further guidance from the FDA, including (but by no means limited to):

Providing examples of ingredients not processed to remove gluten. The only example provided in the final rule is wheat flour. Does this class of ingredients still include hydrolyzed wheat protein and barley malt?

Providing examples of ingredients processed to remove gluten. Does this class of ingredients still include wheat starch hydrolysates?

Clarifying their position on restaurant menu items making a gluten-free claim. A clear yes or no response followed by an explanation would help clear up confusion.

Clarifying which hydrolyzed and fermented ingredients may be included in labeled gluten-free foods while the FDA rule making on foods containing fermented and hydrolyzed ingredients is pending. Is barley malt allowed? Is hydrolyzed wheat protein allowed? Are wheat starch hydrolysates allowed?

There are several parts of the Gluten-Free Labeling Rule that require consumer and manufacturer education. One of the biggest:

Explaining to consumers (especially those who are new to the gluten-free diet) that just because any inherently gluten-free food may be labeled gluten-free, including bottled water and raw carrots does NOT mean that all items purchased at a grocery store must be labeled gluten-free. Many foods and beverages have a low to no risk of cross-contact with gluten-containing grains (e.g., bottled water). While other foods have a much higher risk (e.g., grains and flours).

Just a word about the 20 ppm gluten threshold…

Some of you may have been hoping for a lower gluten threshold level. If so, please take comfort in the results of gluten testing on labeled gluten-free foods that we are seeing at Gluten Free Watchdog. For those of you who will be attending the International Celiac Disease Symposium, Thomas Grace and I have a scientific poster summarizing two years worth of findings. Please come by during the poster sessions and say hello.

There is so much more that could be written but this is enough for now. If you have any questions, please let me know.